.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.Jnj.Com/ .Abiomed, part of Johnson & Johnson Medtech companies, is recruiting for a Sr Clinical Research Associate, located anywhere in the United States. For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.Reporting to the manager of clinical research associates, the person in this role is responsible for the management of day-to-day aspects of investigational site activities on assigned clinical trials. The Clinical Research Associate should ensure compliance with international guidelines, local regulations, and corporate policies and procedures.Key Responsibilities: Study start-up and study conduct activities including drafting ICF study specific template and TMF plan, approving study specific essential documents list, managing, and communicating the status of study progress and activities.Partner with cross-functional teams (e.G., clinical data management, medical teams) with query management, data reviews, and resolution.Provide coaching and training to junior employees.Lead in the investigation of all discrepancies in study documentation, by applying clinical protocol knowledge and GCP and develop processes to mitigate reoccurrence throughout study phases.Conduct reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Abiomed internal SOPs, and US and OUS regulations.Prepare materials for steering and investigator meetings.Conduct site initiation visits; train site personnel onsponsor and regulatory requirements for study conduct; participate in and/or conduct site meetings and prepare site initiation visit reports and associated documentation.Conduct site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with study.Manage monitoring progress of contract & CRO CRAs for respective sites.Develop and deliver technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, and regulatory documentation requirements.Act as a mentor to new or junior level employees